1. Field of the Invention
The present invention relates to a work holder for attaching a handle to a tablet, such as a solid oral dosage form to form a lollipop and to a method for making the same utilizing the work holder.
2. Background Art
A conventional solid oral dosage form of a pharmaceutical attached to a handle for transmucosal active agent delivery is disclosed in U.S. Pat. No. 4,671,953. In addition to being non-invasive and providing a particularly easy method of delivery, the solid oral dosage form attached to a handle allows a patient or caregiver to move the dose in and out of the mouth to titrate the dose. This practice is called dose-to-effect, in which a patient or caregiver controls the administration of the dose until the expected therapeutic effect is achieved. The practice of dose-to-effect is particularly important for certain symptoms, such as pain, nausea, motion sickness, and premedication prior to anesthesia because each patient needs a different amount of medication to treat these symptoms. Once the appropriate amount of active agent is delivered, the patient or caregiver can remove the solid oral dosage form, thus stopping the active agent delivery to prevent overdose.
A common concern with medicated solid oral dosage forms attached to a handle is the possibility that the solid oral dosage form part of the device will become detached from the handle. If the solid oral dosage form becomes detached from the handle, then it can be more difficult to remove and/or administer the active agent as desired. Also of concern is the possibility that the solid oral dosage form which is detached from its handle could be swallowed in its entirety, possibly resulting in an overdosing of the active agent. Similarly, a detached solid oral dosage form could also become a choking hazard.
One method for securely attaching a solid oral dosage form to a handle is the use of mechanical vibrations, such as ultrasonic vibrations, as disclosed in parent application U.S. patent application Ser. No. 11/446,510, filed on Jun. 5, 2006. Such a process involves having the handle inserted into a solid oral dosage form and exerting pressure on the handle with a horn to transmit the vibrations. One problem with attaching several handles and solid oral dosage forms together with the same horn in an automated process is that if the handles are not at the same height, either some handles will not be attached or too much pressure will be applied to some handles resulting in cracking of the solid oral dosage forms.
Therefore, there is a need in the art for a work holder that can hold the tablet portion of a lollipop such as, for example, solid oral dosage forms with the handles inserted therein during an attachment procedure that permits relative movement of the individually assembled handles and tablets. Such a work holder that allows relative movement ensures attachment of all the handles to the tablets and prevents the exertion of too much pressure on some handles, which leads to cracking of the tablets.